Text Messaging for Leukemia

Overseen By Clinical Trials Intake

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must be taking: Mercaptopurine, Methotrexate

Disqualifiers: No cell phone, Does not wish

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether text message reminders can help adolescents and young adults with Acute Lymphoblastic Leukemia (ALL) adhere to their chemotherapy medication schedules. Participants will receive either frequent or less frequent text messages to determine which is more effective. The trial suits individuals aged 15-39 who are beginning maintenance treatment with medications such as mercaptopurine and methotrexate. Participants must have access to a cell phone capable of receiving text messages. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance medication adherence for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to be on a specific treatment regimen that includes mercaptopurine and methotrexate.

What prior data suggests that text messaging is safe for adolescents and young adults with leukemia?

Research shows that using text messages in healthcare is generally safe. Studies have found that patients usually manage mobile health tools, like text messages, effectively. These tools can help people remember to take their medicine as prescribed. Past research has not linked any major problems to receiving text messages. The messages serve as helpful reminders, not treatments that affect the body. Therefore, text messaging is considered low-risk in terms of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using text messaging in leukemia treatment because it introduces a novel way to support patients through their treatment journey. Unlike traditional options that rely on medications and chemotherapy, this approach leverages digital communication to enhance patient engagement and adherence. The high-intensity text messaging arm provides frequent, supportive messages, which could improve emotional well-being and treatment compliance. Meanwhile, the low-intensity arm gradually introduces support, helping researchers understand the optimal level of messaging for patient benefit. This trial could reveal how digital tools can complement medical care and improve outcomes for leukemia patients.

What evidence suggests that text messaging is effective for helping AYA with ALL adhere to chemotherapy medications?

Research has shown that text messaging can help patients remember to take their medications. One study found that sending daily text reminders, along with other support, helped children with short-term illnesses take their medicine on time. Another study found that using text messages and a smart pill bottle improved how well patients followed their oral cancer treatment plans. Patients generally liked receiving text messages as part of their cancer care. In this trial, participants will receive either high-intensity or low-intensity text messaging interventions. These findings suggest that text messaging could help teenagers and young adults with Acute Lymphoblastic Leukemia (ALL) take their chemotherapy medications regularly. ^{6 7 8 9 10}

Who Is on the Research Team?

Wendy Stock, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for young people aged 15-39 who were diagnosed with Acute Lymphoblastic Leukemia (ALL) and are starting maintenance treatment that includes mercaptopurine and methotrexate. They must want to participate and have a cell phone capable of receiving text messages.

Inclusion Criteria

I have been diagnosed with Acute Lymphoblastic Leukemia (ALL).

I was diagnosed with ALL between the ages of 15 and 39.

I am starting maintenance treatment with mercaptopurine and methotrexate.

Exclusion Criteria

I do not want to join the clinical trial.

Patient or caregiver who would receive text message reminders does not have a cell phone that receives text messages

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral mercaptopurine and methotrexate with text message interventions to improve adherence during the first 84-day cycle of maintenance therapy

12 weeks

Regular monitoring visits as per standard of care

Follow-up

Participants are monitored for safety, effectiveness, and clinical outcomes after the treatment phase

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Text Messages

Trial Overview The study tests if text message reminders can help adolescents and young adults take their oral chemotherapy medications more consistently. Participants will receive either high intensity, low intensity, or no text messaging as part of the intervention.

How Is the Trial Designed?

Group I: High Intensity Active Control 1 Intervention

Receives high-intensity text messaging for 2 cycles of treatment

Group II: Low Intensity Active Control 2 Interventions

Receives no texts for 1st cycle and low-intensity texts for 2nd cycle

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7453312/

Effect of a Daily Text Messaging and Directly Supervised ... This randomized clinical trial examines whether a multicomponent intervention results in a higher proportion of pediatric patients with acute ...

2. jdc.jefferson.edu jdc.jefferson.edu/cgi/viewcontent.cgi?article=1301&context=medoncfp

A Smart Pill Bottle and Text Messaging Intervention for ... Survival rates in patients with chronic myeloid leukemia. (CML) significantly increased with the advent of the first tyrosine kinase inhibitor ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8307703/

Text Messaging in Cancer-Supportive Care - PubMed Central Overall, patients were satisfied with using text-based communication in their cancer care. Results were inconsistent within other outcome ...

4. mhealth.jmir.org mhealth.jmir.org/2017/12/e184/

Mobile Health Intervention to Increase Oral Cancer Therapy ... Results: The intervention comprised 2 synergistically operating elements: (1) daily medication reminders and routine assessment of side effects ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05595135?cond=Cancer&intr=navigation&term=txt4aml&rank=1

Mobile Intervention to Improve Adherence of Oral Anti- ... This clinical trial studies how well a mobile intervention consisting of a text messaging program and an electronic "smart" pill bottle with medication ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32852553/

Effect of a Daily Text Messaging and Directly Supervised ... Data analysis was performed from February to October 2019. Interventions: Patients were randomized 1:1 to education alone or the intervention ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2769841

Effect of a Daily Text Messaging and Directly Supervised ... This study provides evidence for limiting future trials to older children with acute lymphoblastic leukemia who have low baseline adherence to oral ...

8. ons.org ons.org/publications-research/cjon/25/4/mobile-health-interventions-examining-medication-adherence-outcomes

Mobile Health Interventions: Examining Medication ... Mobile health interventions are an acceptable approach among patients with cancer and may improve adherence outcomes for those at highest risk for suboptimal ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06446661

Using Text Messages to Improve Oral Chemotherapy for ... This study aims to compare adherence to oral mercaptopurine and methotrexate during the first 84-day cycle of maintenance therapy for adolescent and young adult ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12103477/

A smart pill bottle and text messaging intervention ... The intervention consists of unprompted messages with topic keywords provided to participants for additional tips or coping strategies.